The Naples Pediatric Food Allergy (NAPFA) Score
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Development of a new clinical score for the identification of pediatric FA in primary care setting
研究概览
简要总结
Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Week 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects aged between 0-14 years with suggestive history of food allergy
排除标准
- •Exclusion criteria: age >14 years
- •chronic systemic diseases,
- •malignancy,
- •immunodeficiency,
- •infectious diseases,
- •autoimmune diseases,
- •inflammatory bowel diseases,
- •celiac disease,
- •metabolic and genetic diseases,
- •cystic fibrosis,
- •chronic pulmonary diseases,
- •gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
- •neurologic and/or neuropsychiatric disorders,
- •gastrointestinal tract eosinophilic disorders,
- •use of immunomodulating drugs in the previous 4 months
- •use of steroids and antihistamines in the previous 2 weeks
结局指标
主要结局
Development of a new clinical score for the identification of pediatric FA in primary care setting
时间窗: at the enrollment
The score will include the main anamnestic and clinical features
次要结局
- Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting(at the enrollment)
- Validation of the new clinical NAPFA score for the identification of pediatric FA(at the enrollment)
研究者
Roberto Berni Canani, MD, PhD
Professor of Pediatrics
Federico II University